Evaluation of Prognostic Monitoring for Women Who Have Co... | NCT05410015

Studies
Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Treatment for Ovarian Cancer

NCT05410015

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Jun 8, 2022Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Ovarian Cancer

Interventions

Normal clinical treatment without intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 3, 2022Actual

Primary Completion Date

Feb 3, 2024Estimated

Completion Date

Feb 3, 2026Estimated

First Submitted Date

Jun 4, 2022

First Submission Date that Met QC Criteria

Jun 4, 2022

First Posted Date

Jun 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2022

Last Update Posted Date

Jun 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The relationship between immune inflammation-related protein complexes inblood and recurrence or metastasis of ovarian cancer will be studied

Detailed Description

100 cases in normal ovarian control group, 100 cases in benign ovarian disease group and 100 cases in malignant ovarian epithelial carcinoma group will be studied. Change regularity of ovarian cancer specific immune inflammation-related protein complexes in blood will be studied. The relationship between disease-specific protein complexes and pathological state of patients will be analyzed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Normal clinical treatment without intervention	Other	Normal clinical treatment without intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immune Inflammation-Related Protein Pomplexes	The change of immune inflammation-related protein complexes	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female
Normal ovary control
Ovarian benign disease
Ovarian malignant epithelial carcinoma

Exclusion Criteria:

Male
Age above 70
Suffering from other malignant tumors
Non-compliant patient

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

The study population included normal ovarian controls, patients with benign ovarian disease, and patients with malignant epithelial ovarian cancer.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peng Peng, MD	Contact	+86-13521361934		pengp1999@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital	Recruiting	Beijing	Beijing Municipality		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008722	Methods

Ancestor Terms

ID	Term
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided